BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INRATIO

    MDR report key: 3111861 · Received May 7, 2013

    Report

    Report Number
    2027969-2013-00374
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ALERE SAN DIEGO INC.
    Product Code
    GJS
    PMA / PMN Number
    K092987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED INRATIO RESULT 5.2. CLSI STATES, "RESULTS EXCEEDING AN INR OF 5.0 GENERALLY HAVE REDUCED TRUENESS, PRECISION AND LINEARITY, BOTH IN POC AND LABORATORY BASED PT TESTING" (REF 9.4). DISCREPANT RESULTS (ACCURACY) COMPARISON OF INRATIO TEST WITH REFERENCE RESULTS PROVIDED BY END-USER AT TIME COMPLAINT WAS FILED: (B)(6) 2013, INRATIO: 5.2, REFERENCE: 1.65, MEAN: 3.43, CONFIDENCE LIMITS: 2.0 - 5.0. THE MEAN OF THE INRATIO METER AND COMPARATIVE SYSTEM INR WERE CALCULATED. BOTH INRATIO AND REFERENCE VALUES FALL OUTSIDE THE LIMITS, SO THE CRITERIA WAS NOT MET AND THE VALUES ARE DISCREPANT BEYOND THE DOCUMENTED VARIABILITY FOR PT/INR TESTING. THIS WOULD BE SUBJECT TO STRIP ACCURACY TESTING AS PART OF THE COMPLAINT INVESTIGATION. THE LAST IN-HOUSE THERAPEUTIC DONOR TESTING PERFORMED ON THE REPORTED LOT 299623 ON (B)(4) 2013 YIELDED THE FOLLOWING RESULTS: DONOR 1: INRATIO: 2.7, 2.7, 2.7, REFERENCE: 2.93, BIAS THRESHOLD: 1.93, 3.93, %CV: 0.00. DONOR 2: INRATIO: 2.4, 2.6, 2.4, REFERENCE: 2.01, BIAS THRESHOLD: 1.01, 3.301, %CV: 4.68. ALL REPLICATES FOR EACH DONOR WERE WITHIN THE ACCEPTABLE BIAS FOR ACCURACY. PRODUCT PERFORMED AS EXPECTED. BOTH DONORS PRODUCED %CV LESS THAN 16%. PRECISION CRITERIA HAD BEEN MET. NO FURTHER INVESTIGATION REQUIRED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2013, INRATIO: 1.65, LAB: 5.2. THERAPEUTIC RANGE: 2.0-3.0. TIME: TESTS WERE TAKEN LESS THAN 30 MINUTES APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198035 INRATIO PROTHROMBIN TIME TEST GJS ALERE SAN DIEGO INC. 100139 299623

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN